The main aim of this study was to investigate the Low Level Lasers (LLL) efficacy in alleviating the symptoms associated with knee OA. This is a single blind clinical trial in which that 36 adults patients (aged 45-75 years old) with knee OA participated in this study. The patients were randomly assigned to receive active laser with standard treatment or placebo laser with standard treatment. In the intervention group, a Gal-Al-As diode laser device with a power output of 30 mW and a wavelength of 830 nm was used that the probe was applied in grid cycloid form in ten points on the medial and lateral joint line. In the placebo group, the same points and the similar duration was applied while turned off the laser device. The standard treatment was 1-Ultrasound 2- TENS current 3-Infra Red radiation 4- Straight Leg Raising in supine position. They were treated for ten session¸ 5 times weekly and in period of two weeks. Pain at rest, duration of morning stiffness, active range of knee flexion, and the quality of life with WOMAC index were assessed before and after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010104549N2
Registration date:2010-10-24, 1389/08/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-10-24, 1389/08/02
Registrant information
Name
Elham Fatemy
Name of organization / entity
Semnan University Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1335 4180
Email address
fatemy@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2009-09-29, 1388/07/07
Expected recruitment end date
2010-01-26, 1388/11/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of low level laser on knee osteoarthritis treatment
Public title
Efficacy of laser on knee Arthrosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of Idiopathic unilateral knee OA, age 45-75 years, ability of walking, having local pain in the knee region that was greater than 5 with regard to VAS and greater than 48 with regard to the WOMAC scale,
Exclusion criteria: having other disorders of knee, affecting hip and ankle joints, lumbar spine pathology, presence of intra-articular effusion, past history of physical therapy or injection into the joint space since 6 months ago, presence of any infection, active bleeding, past history of knee joint surgery
Age
From 45 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Kilometer 5, Damghan Road
City
Semnan
Postal code
3513138111
Approval date
empty
Ethics committee reference number
9 /12901/ آ
Health conditions studied
1
Description of health condition studied
Osteoarthritis of the knee joint
ICD-10 code
M19.0
ICD-10 code description
Primary arthrosis of other joints
Primary outcomes
1
Description
pain at rest
Timepoint
before first session and after tenth session
Method of measurement
on basis of VAS
2
Description
duration of morning stiffness
Timepoint
in the onset of first session and after the final session
Method of measurement
recording of the duration via the patients at minute and quastion of their
3
Description
Active Kee flexion Range of Motion
Timepoint
onset of first session and after the tenth session
Method of measurement
via the goniometer by therapist
4
Description
Quality of life
Timepoint
onset of first session and after the tenth session
Method of measurement
via questioning of patients on the basis of WOMAC index
Secondary outcomes
empty
Intervention groups
1
Description
The standard treatment that applied to the each of two groups was 1-A 1 MHz continous mode Ultrasound with applicator cross section of 0/8 cm2 in medial and lateral aspect of joint line, duration of 5 min and intensity of 1 w/cm2 .2- TENS current with frequency of 100 Hz and pulse duration of 0/05 ms and the time of treatment of 15 min.3-Infra Red radiation with power of 250 watt and 45 cm distance from the knee4- SLR in supine position, 30 fold. In the control group A Gal-Al-As diode laser device with a power output of 30 mW and a wavelength of 830 nm was used. Probe of laser applied in pattern of cycloid grid in 5 points in antero-medial side and 5 points in the antero-lateral side of knee joint line. In Each session 3 j/per point and a total dosage of 30j/cm2 were applied. In the placebo group, the same points and the similar duration was applied while turned off the laser device.
Category
Rehabilitation
2
Description
The standard treatment that applied for the control group was 1-A 1 MHz continous mode Ultrasound with applicator cross section of 0/8 cm2 in medial and lateral aspect of joint line, duration of 5 min and intensity of 1 w/cm2 .2- TENS current with frequency of 100 Hz and pulse duration of 0/05 ms and the time of treatment of 15 min.3-Infra Red radiation with power of 250 watt and 45 cm distance from the knee 4- Straight Leg Raising in supine position, 30 fold. The same Gal-Al-As diode laser device was applied on the same points as the Active laser group while turned off the laser device. Probe of laser was applied in pattern of cycloid grid in 5 points in antero-medial side and 5 points in the antero-lateral side of knee joint line. The duration of treatment on each point was 30 second.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
The Rehabilitation Center of Tabatabaee
Full name of responsible person
Street address
Mashahir Square, in front of Helal Ahmar
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Elham Fatemi
Street address
Department of Physiotherapy, Rehabilitation Faculty, Semnan University of Medical Sciences
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tarbiat Modares University of Tehran
Full name of responsible person
Rasool Bagheri
Position
Student of Master Science
Other areas of specialty/work
Street address
Highway of Jalal Ale Ahmad, Tarbiat Modares University, Department of Physiotherapy
City
Tehran
Postal code
Phone
+98 23 1446 1580
Fax
Email
rasool.bagheri@ymail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University of Tehran
Full name of responsible person
Rasool Bagheri
Position
Student of Master Science
Other areas of specialty/work
Street address
Jalal Ale Ahmad Highway, Tarbiat Modares University,Department of Physiotherapy
City
Tehran
Postal code
Phone
+98 23 1446 1580
Fax
Email
rasool.bagheri@ymail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Rasool Bagheri
Position
Student of Master Science
Other areas of specialty/work
Street address
Department of Physiotherapy, Tarbiat Modares University, Jalal Ale Ahmad HighWay,
City
Postal code
Phone
Fax
Email
rasool.bagheri@ymail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)